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FDA Reiterates: Pharma Not Responsible for UGC

Intouch Team

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Until earlier this year, the FDA had provided no specific guidance outlining whether pharmaceutical companies will be held accountable for user-generated comments on social media platforms like Facebook. As a result of this lack of clarity, pharma companies have been slow to embrace those social channels that don’t offer pre-moderation or disabling of comments for fear of being issued a warning letter if a user were to post a comment about off-label use, inappropriate/inaccurate claims or promotional messaging on unbranded channels.

The hypothetical scenario of “AcmeDrug has cured my cancer!” posted on a channel where fair balance is not present has been the topic of many medical/legal/regulatory conversations with brand managers who are interested in engaging in the social space.

Until the January publication of the draft guidance on the post-marketing submission of interactive promotional media, it was a question of whether the pharma company could balance the benefit of engaging with the risk that the FDA would hold them accountable for user-generated content (UGC).

While still in draft format, the FDA has provided direction to pharma marketers that they are clear to engage with their communities without fear of the content in user-generated comments. Within the draft guidance, the FDA stated:

FDA will not ordinarily view UGC on firm-owned or firm-controlled venues such as blogs, message boards, and chat rooms as promotional content on behalf of the firm as long as the user has no affiliation with the firm and the firm had no influences on the UGC.

And additional, related draft guidance just released this week reiterates that:

Firms are generally not responsible for third-party UGC about their products when the UGC is truly independent of the firm (e.g., is not produced by, or on behalf of, or prompted by the firm in any particular) regardless of whether the firm owns or operates the platform on which the communication appears.

In the scenario previously mentioned, in theory, this means AcmeDrug would not be held responsible for a fan’s off-label cure claim or promotional comment — thus, AcmeDrug would not need to remove it from its Facebook page.

However, when we reference FDA’s earlier AMARC letter, it’s clear certain responses to the UGC on behalf of the brand — such as liking the comment, adding the comment to the brand’s list of favorite tweets, retweeting/sharing or posting a response — could present complications. For instance, a user-generated comment might be attributed to AcmeDrug in either of the following examples. The first example is rooted in the scenario that resulted in the AMARC letter, and the second is a reasonable expansion of that principle.

Example 1: AcmeDrug “likes” the comment. In December 2012, AMARC Enterprises received an FDA letter related, in part, to a Facebook page it maintained for its dietary supplement Poly-MVA®. On that page, a Facebook user posted an off-label claim: “PolyMVA has done wonders for me. I take it intravenously 2x a week and it has helped me tremendously. It enabled me to keep cancer at bay without the use of chemo and radiation…Thank you AMARC.” The Poly-MVA Facebook Page “liked” the user comment, which the FDA found to be an endorsement of the off-label usage and claim.

It’s worth noting the FDA had many, many additional concerns about this otherwise overly aggressive and egregious Facebook page. Nevertheless the letter gives us a view of the FDA’s thinking on the topic of social endorsements.

Example 2: AcmeDrug “boosts” or “promotes” the post after a user adds a comment mentioning an off-label use or provide misinformation. Some social media platforms, like Facebook, allow Page owners to amplify the exposure of a post by boosting or promoting it. Both are forms of paid media used to increase reach, and both require one special note of consideration: If the Page owner boosts or promotes the post after it has been commented on by Facebook users, the Page owner needs to ensure that none of the user comments made to the post prior to boosting or promoting mention off-label use or provide misinformation. Otherwise, the FDA might see the boosted or promoted post as an endorsement.

Aside from whether a pharma company would need to remove a user-generated comment or avoid “liking” a user-generated comment for the purpose of FDA compliance, there might be other reasons to do so. This is where risk tolerance comes into play and where terms of use and moderation policies come in handy. Terms of use establish public community guidelines that provide parameters for acceptable comments, and moderation policies help ensure a consistent internal approach to liking or responding to user comments.

Finally it’s also worth noting that FDA’s most recent social media guidance states that, if a pharma company “owns or operates” the platform or created or initiated the forum (such as a Facebook page) on which UGC appears, the firm should include an overarching clear and conspicuous statement that the firm did not create or control the UGC. This can easily be worked into most terms and conditions statements, if it’s not there already.

Beyond UGC
While recent FDA guidance should open opportunities for pharma marketers to engage, there are of course many known, long-standing rules that should be kept in mind. One such rule of thumb is that pharma companies can control their marketing pertaining to promotional messaging and fair balance. To comply with DTC regulations, Important Safety Information (ISI) is required whenever a brand name and claim are used together. Another rule of thumb relates more to user-generated content: When any piece of user-generated content mentions adverse effects (AE), keep in mind that AEs must be reported. Each brand typically has clear reporting guidelines in terms of format and time.

Facebook and other popular social media platforms provide pharma companies with big opportunities to connect with their communities, but understanding and following FDA guidelines will always be a critical element. Fortunately, January’s draft guidance provided a clearer understanding of when a page owner is and is not considered responsible for user-generated comments posted in its Facebook community.

For more background and analysis of FDA’s guidance, see Intouch Solutions’ POV on the topic, FDA Guidance Reveals Openness to Pharma Social.

This information is for general guidance on matters of interest only and is not, nor is it intended to be, legal advice.



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